Pharmaceutical manufacturing involves the development of drug products that effectively deliver pharmaceutically active compositions to patients. During the development of such processes, properties of the formulation including bioavailability, drug loading, appearance, and disintegration profile are generally tailored to the specific needs of the patient to whom the drug will be administered. To date, tablets and capsules are some of the most common oral drug delivery systems because of their low manufacturing cost, acceptable forms, designable disintegration profiles, and portable conveniences. Generally, tablets and capsules are designed with one particular pharmaceutically active composition in mind, and include predetermined pharmacological, stability, and manufacturing properties. When the pharmaceutically active composition is of the wrong size, shape, or bulk density, additional steps such as milling and wet granulation are often employed to ensure content uniformity. Common problems in tablet or capsule manufacturing often include lack of pharmaceutically active composition uniformity, loss of powder during operation, and/or uneven powder flow, all of which unnecessarily increase the manufacturing cost, compromise precision, and extend product development.
Recently, a new drug delivery system, fast dissolving oral films, was developed based on the technology of the transdermal patch. Generally, in such systems, a thin strip is designed to be placed on the patient's tongue, where it can become wet and adhere at the site of application. In many cases, the manufacturing costs of oral films are competitive with those of conventional tablets. Generally, thin film manufacturing can reduce cost due to its solution-based approach and its large surface area, and because solid handling and drying time are reduced. These advantages can be magnified when the pharmaceutically active composition is hard to disperse well in a solid form and/or when the pharmaceutically active composition is difficult to handle, both of which can lead to a reduction in pharmaceutically active composition yield and increased cost.
However, the fast disintegration and rapid lease features of thin-film oral strips tend to limit their application to pharmaceutically active compositions compatible with a fast release profile in the patient's mouth. In addition, thin films can have disadvantages associated with their transport; thin films can be difficult to carry, store, and/or handle because of their fragility and general lack of mechanical robustness.
Accordingly, improved systems and methods for producing ingestible pharmaceutical products would be desirable.